A Phase 3 Clinical Study of KHK 4827

Phase 3

Completed

• Conditions: Psoriatic Arthritis; Pustular; Psoriasis, Palmaris Et Plantaris; Psoriasis Vulgaris; Psoriatic Erythroderma
• Interventions: Drug: KHK4827 140mg SC; Drug: KHK4827 210mg SC

• Registration Number: NCT02052609
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

This study is designed to evaluate the safety and efficacy of long-term exposure to KHK4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-30
• Study Start: 2014-02
• Study First Posted: 2014-02-03
• Primary Completion: 2015-01-28
• Study Completion: 2016-07-04
• Status Verified: 2019-11
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

• Subject has voluntarily signed the written informed consent form to participate in this study
• Subject has completed the week 52 evaluation either in Study 003 or 004

Exclusion Criteria

• Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
• Subject has been judged to be ineligible for participation in the study by the investigators/sub investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KHK4827 140mg SC	KHK4827 140mg SC	-
KHK4827 210mg SC	KHK4827 210mg SC	-

Primary Outcome Measures

Name	Time	Method
Anti-KHK4827 antibody	28 weeks
Incidence and types of adverse events and adverse reactions	28 weeks

Secondary Outcome Measures

Name	Time	Method
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"	28 Weeks
Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.	28 weeks
Clinical Global Impression (CGI)	28 weeks
Percent improvement in PASI	28 Weeks
PASI 50, 75, 90, and 100	28 Weeks
sPGA of "0 (clear)	28 weeks
Change in body surface area involvement (BSA) of lesion	28 weeks
Pustular symptom score	28 weeks
Serum KHK4827 concentration	28 weeks
American College of Rheumatology (ACR) 20	28 weeks

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact Kyowa Kirin; 🇯🇵 Chiyoda-ku, Tokyo, Japan